Sterile assembly for a prefilled syringe and a syringe containing said assembly

Abstract

A sterile assembly for a prefilled flushing syringe. The sterile assembly includes a scrub cap and a sterile cap. The scrub cap includes a chamber adapted to receive a needleless connector of an intravenous (IV) catheter. A scrubber and a sterilant are contained within the chamber of the scrub cap. The sterile cap includes a chamber adapted to receive the needleless connector of the IV catheter. A compressible sponge and a sterilant are contained within the chamber of the sterile cap. The sterile cap is detachably connected to the scrub cap. A tip cap adapted to connect to and encapsulate the syringe tip of the syringe extends from one of the sterile cap and the scrub cap or from a housing connecting the sterile cap and the scrub cap. Also provided are a prefilled flushing syringe including the sterile assembly, and a method for sterilizing needleless connectors and catheters using the prefilled flushing syringe.

Description

[Technical Field]

[0001] The present invention relates to a sterile assembly for a prefilled flushing syringe, and more particularly to a sterile assembly including a scrub cap and a sterilization cap, and a prefilled flushing syringe including the sterile assembly. [Background technology]

[0002] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Application No. 18 / 071,072, entitled "Disinfecting Assembly for a Prefilled Syringe and Syringe Including Such an Assembly," filed November 29, 2022, which is incorporated herein by reference.

[0003] Description of Related Art Intravascular (IV) catheter care and practice standards often recommend flush procedures after IV catheter placement, before infusion, and before and after medication administration, blood withdrawal, transfusion, and parenteral nutrition. Such procedures are outlined, for example, in the INS 2021 Infusion Therapy Practice Standards. The purpose of these flush procedures is to confirm IV catheter patency, avoid medication incompatibilities, ensure complete administration of medications, prevent thrombus formation, and minimize the risk of bloodstream infections.

[0004] Bloodstream infections associated with IV catheters are common and result from bacterial, fungal, and other infectious agents in patients with indwelling IV catheters. These infections can result in significant morbidity or mortality, as well as excessive healthcare costs. The currently recommended approach is for healthcare professionals to perform a stepwise sterilization procedure each time an indwelling IV catheter is accessed. This procedure requires several steps, including cleaning and sterilizing the needleless connector of the indwelling IV catheter before the start of a procedure; pre-flushing the needleless connector and the indwelling IV catheter with a flush solution (e.g., saline) before injecting a medication or withdrawing fluid through the needleless connector and the indwelling IV catheter; cleaning and sterilizing the needleless connector of the indwelling IV catheter after the pre-flushing; performing the medication or fluid withdrawal; cleaning and sterilizing the needleless connector of the IV catheter after the medication or fluid withdrawal; post-flushing the needleless connector or IV line with a flush solution; locking the IV catheter; cleaning and sterilizing the needleless connector of the IV catheter; and encapsulating the needleless connector of the IV catheter. Additionally, the procedure requires four sterile wipes, two flushing syringes, one locking syringe, and one cap. This extensive process makes IV catheterization and IV catheter line maintenance a very tedious and time-consuming task. In addition, many of the components are provided separately, and healthcare professionals must assemble them before beginning the procedure. Summary of the Invention [Problem to be solved by the invention]

[0005] Therefore, there is a need for an assembly that provides all of the necessary components in a single device to encourage medical personnel to adhere to all of the necessary sterilization procedures and to reduce costs. [Means for solving the problem]

[0006] The present invention relates to a sterile assembly for prefilled flushing syringes. The sterile assembly includes a scrubbing cap and a sterilization cap. The scrubbing cap includes an open proximal end, a closed distal end, a sidewall extending from the open proximal end to the closed distal end of the scrubbing cap, a chamber defined by the sidewall of the scrubbing cap together with the closed distal end and having a size and shape to receive a needleless connector of an intravenous (IV) catheter, and a scrubber and a sterilant contained within the chamber of the scrubbing cap. The sterilization cap includes an open proximal end, a closed distal end, a sidewall extending from the open proximal end to the closed distal end of the sterilization cap, a chamber defined by the sidewall of the sterilization cap together with the closed distal end and having a size and shape to receive a needleless connector of an IV catheter, and a compressible sponge and a sterilant contained within the chamber of the sterilization cap. The sterilization cap is detachably connected to the scrubbing cap.

[0007] The scrubber may fill at least a portion of the chamber of the scrubbing cap. The scrubber may be saturated with sterilant and / or secured to a proximal portion of the chamber of the scrubbing cap, with the sterilant contained in a distal portion of the chamber of the scrubbing cap. The scrubber may be retained in the proximal portion of the scrubbing cap by interaction between a peripheral flange extending radially outward from the scrubber and a ledge extending radially inward from the inner surface of the sidewall of the scrubbing cap.

[0008] The outer diameter of the proximal portion of the scrubbing cap may be larger than the outer diameter of the distal portion of the scrubbing cap, and / or the inner diameter of the proximal portion of the scrubbing cap may be larger than the inner diameter of the distal portion of the scrubbing cap. The scrubber may be substantially contained within the proximal portion of the scrubbing cap.

[0009] The scrubber may have at least one slit and / or at least one recess at a proximal end of the scrubber, the at least one slit and / or the at least one recess adapted to receive a needleless connector of an IV catheter when the needleless connector is inserted into the scrubbing cap.

[0010] The removable cover may seal the open proximal end of the scrubbing cap. The removable cover may be a film adhered to the open proximal end of the scrubbing cap. The removable cover may include a pull tab extending outward from a seal of the removable cover. The peripheral flange may extend radially outward from the open proximal end of the scrubbing cap with the removable cover adhered to the peripheral flange.

[0011] The sponge may fill at least a portion of the cavity of the sterilization cap.The sterilization cap may be provided with a thread on the inner surface of the side wall.

[0012] The open proximal end of the sterile cap may be sealed by a removable cover. The removable cover may be a film adhered to the open proximal end of the sterile cap. The removable cover may include a pull tab extending outward from a seal of the removable cover. The peripheral flange may extend radially outward from the proximal end of the sterile cap with the removable cover adhered to the peripheral flange.

[0013] Protrusions may extend radially outward from the outer surface of the side wall of the scrub cap to assist the user in gripping the scrub cap during removal of the removable cover and scrubbing the needleless connector, and / or protrusions may extend radially outward from the outer surface of the side wall of the sterility cap to assist the user in gripping the sterility cap during removal of the removable cover and placement of the sterility cap on the needleless connector.

[0014] The sterilization assembly may further include a tip cap extending distally from the closed distal end of one of the sterilization cap and the scrub cap and adapted to connect to and encase a syringe tip of a prefilled syringe. The tip cap may include a closed proximal end, an open distal end, and a sidewall extending from the closed proximal end to the open distal end. The sidewall of the tip cap, together with the closed proximal end of the tip cap, may define a cavity sized and shaped to receive and encase the syringe tip of the syringe. The sidewall of the tip cap may be provided with external threads adapted to engage with the internal threads of a luer lock surrounding the syringe tip.

[0015] The closed distal end of one of the sterilization cap and the scrub cap may be coupled to an open proximal end of the other of the sterilization cap and the scrub cap. The open proximal end of the one of the sterilization cap and the scrub cap may include a retainer including a peripheral flange extending radially outward from the open proximal end of the one of the sterilization cap and the scrub cap and a retaining sidewall extending distally from an outer periphery of the peripheral flange. The closed distal end of the other of the sterilization cap and the scrub cap is received in the retainer.

[0016] One of the sterilization cap and the scrub cap may be attached to the other of the sterilization cap and the scrub cap via a removable disk. The open proximal end of one of the sterilization cap and the scrub cap may have a retaining portion for removably attaching the disk. The retaining portion may include a peripheral flange extending radially outward from the open proximal end of one of the sterilization cap and the scrub cap and a retaining sidewall extending distally from the outer periphery of the peripheral flange. The disk rests on the peripheral flange of the retaining portion and is held in place by the retaining flange extending radially inward around at least a portion of the proximal end of the retaining sidewall, allowing the disk to be in snap-fit ​​engagement with one of the sterilization cap and the scrub cap. At the closed distal end of the other of the sterilization cap and the scrub cap, a circumferential groove may be provided on the outer surface of the sidewall of the other of the sterilization cap and the scrub cap. A flexible annular projection extends proximally from the disk and is received in snap-fit ​​engagement in the circumferential groove.

[0017] The scrub cap and the sterilization cap may be connected by a housing. The housing may include an open proximal end, a closed distal end, and a sidewall extending from the open proximal end to the closed distal end. The sidewall of the housing, together with the closed distal end of the housing, defines a cavity sized and shaped to receive one of the sterilization cap and the scrub cap and at least a portion of the other of the sterilization cap and the scrub cap.

[0018] A tip cap adapted to connect to and encapsulate the syringe tip of the prefilled syringe may extend distally from the closed distal end of the housing. The tip cap may include a closed proximal end, an open distal end, and a sidewall extending from the closed proximal end to the open distal end. The sidewall of the tip cap, together with the closed proximal end of the tip cap, defines a cavity sized and shaped to receive and encapsulate the syringe tip of the syringe.

[0019] The housing may include a body portion and a retaining portion, and one of the sterilization cap and the scrub cap may be connected to the retaining portion of the housing. The inner diameter of the retaining portion of the housing may be larger than the inner diameter of the body portion of the housing, and / or the outer diameter of the retaining portion of the housing may be larger than the outer diameter of the body portion of the housing.

[0020] The sidewall of the housing may include a recess through which a pull tab of a removable cover of one of the sterilization cap and the scrub cap extends.

[0021] One of the sterilization cap and the scrub cap may be positioned within the cavity of the housing such that the closed distal end of one of the sterilization cap and the scrub cap rests on the closed distal end of the housing, the closed distal end of the other of the sterilization cap and the scrub cap is received within the cavity of the housing and removably connected to the housing, the open proximal end of one of the sterilization cap and the scrub cap is adjacent to the closed distal end of the other of the sterilization cap and the scrub cap, and the open proximal end of the other of the sterilization cap and the scrub cap extends proximally from the housing.

[0022] A flexible annular projection may extend radially inward from the inner surface of the side wall of the housing, and a peripheral groove may be provided on the outer surface of the side wall of one of the sterilization cap and the scrub cap, and the annular projection of the housing may be removably received in the peripheral groove by a snap-fit ​​engagement to connect one of the sterilization cap and the scrub cap to the housing.

[0023] Alternatively, a peripheral groove may be provided on the inner surface of the side wall of the housing, and a flexible annular projection may extend radially outward from the outer surface of the side wall of one of the sterilization cap and the scrub cap, with the annular projection removably received in the peripheral groove by a snap-fit ​​engagement to connect one of the sterilization cap and the scrub cap to the housing.

[0024] Alternatively, one of the sterilization cap and the scrub cap may be attached to the housing by threads on the inner surface of the side wall of the housing, a circumferential attachment flange extending proximally from the outer surface of the side wall of one of the sterilization cap and the scrub cap, threads on the outer surface of the attachment flange, and threads on the outer surface of the attachment flange engaging threads on the inner surface of the side wall of the housing.

[0025] The present invention is also directed to a pre-filled flushing syringe, comprising a syringe including a chamber having a syringe tip, the syringe tip defining a lumen having an opening for discharging flush solution from the chamber, and the sterile assembly as described above, the sterile assembly and syringe being connected by an engagement portion provided between the tip cap and the syringe tip.

[0026] The present invention is also directed to a method for sterilizing an indwelling IV catheter. A prefilled flushing syringe with a sterilization assembly is provided, as described above. A sterilization cap is separated from a scrub cap. A removable cover is removed from the scrub cap. A needleless connector of an IV catheter is inserted into a chamber of the scrub cap. The needleless connector is longitudinally moved and / or rotated relative to a scrubber to scrub the needleless connector and wash the needleless connector with a sterilant. Either the sterilization cap or the scrub cap, which is connected to a syringe, is removed from the syringe. A syringe is connected to the needleless connector, and the needleless connector and IV catheter are flushed with a flush solution. The syringe is separated from the needleless connector. The needleless connector is encapsulated with a sterilization cap.

[0027] Alternatively, a prefilled flushing syringe with a sterile assembly is provided as described above. A sterile or scrub cap is separated from the housing. A removable cover is removed from the scrub cap. The needleless connector of the IV catheter is inserted into the chamber of the scrub cap. The needleless connector is longitudinally moved and / or rotated relative to the scrubber to scrub the needleless connector and clean the needleless connector with a sterilant. The housing is separated from the syringe. The syringe is connected to the needleless connector and the needleless connector and IV catheter are flushed with a flush solution. The syringe is separated from the needleless connector. The needleless connector is encapsulated with a sterile cap. [Brief explanation of the drawings]

[0028] [Figure 1] 1 is a cross-sectional view of a first embodiment of a sterilization assembly according to the present invention. [Figure 2] FIG. 2 is an exploded side perspective view of the sterilization assembly of FIG. 1. [Figure 3] 2 is a side view of a syringe including the sterile assembly of FIG. 1 according to the present invention. [Figure 4] FIG. 2 is a schematic diagram showing the sterilization assembly of FIG. 1 in use. [Figure 5] FIG. 2 is a cross-sectional view of a second embodiment of a sterilization assembly according to the present invention. [Figure 6] FIG. 10 is a cross-sectional view of a third embodiment of a sterilization assembly according to the present invention. [Figure 7] 7 is a side view of a syringe including the sterile assembly of FIG. 6 according to the present invention. [Figure 8] FIG. 7 is a schematic diagram showing the sterilization assembly of FIG. 6 in use. [Figure 9] FIG. 10 is a cross-sectional view of a fourth embodiment of a sterilization assembly according to the present invention. [Figure 10] FIG. 10 is a side perspective view of a fifth embodiment of a sterilization assembly according to the present invention. [Figure 11] FIG. 11 is a cross-sectional view of the sterilization assembly of FIG. [Figure 12]11 is a side view of a syringe including the sterilization assembly of FIG. 10 according to the present invention. [Figure 13] FIG. 11 is a schematic diagram showing the sterilization assembly of FIG. 10 in use. [Figure 14] FIG. 10 is a cross-sectional view of a sixth embodiment of a sterilization assembly according to the present invention. [Figure 15] FIG. 10 is a cross-sectional view of a seventh embodiment of a sterilization assembly according to the present invention. [Figure 16] 16 is a side view of a syringe including the sterilization assembly of FIG. 15 according to the present invention. [Figure 17] FIG. 16 is a schematic diagram showing the sterilization assembly of FIG. 15 in use. [Figure 18] FIG. 13 is a cross-sectional view of an eighth embodiment of a sterilization assembly according to the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0029] As used herein, all numerical values ​​are expressed using periods as decimal points and commas as thousands separators; for example, 1,234 is one thousand two hundred and thirty-four, and 1.2 is one and two-tenths. Unless expressly specified, all numerical values, such as numerical values ​​expressing numbers, ranges, amounts, and percentages, may be understood as preceded by the term "about," even if the term "about" is not explicitly stated. Numerical ranges recited herein are intended to include all subranges encompassed therein. For example, a range "1 to 10" is intended to include all subranges (inclusive) between the stated minimum value of 1 and the stated maximum value of 10, i.e., all subranges (inclusive) beginning with a minimum value of 1 or greater and ending with a maximum value of 10 or less, e.g., 1 to 6.3, or 5.5 to 10, or 2.7 to 6.1. Plurals include the singular, and vice versa. When ranges are given, the endpoints of those ranges and / or numerical values ​​within those ranges can be combined into the scope of the invention. The terms "including," "such as," "for example," etc. mean "including but not limited to / such as but not limited to / for example, but not limited to."

[0030] In the following description, terms relating to spatial orientation, such as "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," "proximal," "distal," and derivatives thereof, refer to the present invention as oriented in the drawings, unless otherwise specified in the detailed description below. However, it should be understood that the present invention may assume various alternative modifications. It should also be understood that the specific components, devices, features, and sequences of operation illustrated in the accompanying drawings, figures, or otherwise described herein are merely exemplary and should not be considered limiting.

[0031] As used herein, "proximal" refers to the end of the device and in the direction indicated by the arrow "P" in the figures, and "distal" refers to the end of the device and in the direction indicated by the arrow "D" in the figures.

[0032] The present invention is directed to sterile assemblies 10a-10h for prefilled flushing syringes and prefilled flushing syringes 12 that include the sterile assemblies 10a-10h.

[0033] Sterile assemblies 10a-10h are for use with standard prefilled syringes. As shown in Figures 3, 7, 12, and 16, syringe 12 includes a syringe body 14 having a syringe tip 18 defining a chamber 16 for holding flush solution and having a lumen 20 with an opening 22 through which the flush solution can be expelled from chamber 16. Syringe tip 18 may be, for example, a male Luer taper and surrounded by a threaded Luer lock 24. Syringe tip 18 may be removably attached to a needleless connector 26 of an indwelling intravenous (IV) catheter. A plunger rod 28 attached to a stopper 30 disposed within the chamber 16 of the syringe body 14 is movable relative to the syringe body 14, and a distal force applied to the plunger rod 28 while the syringe body 14 remains stationary causes the attached stopper to move distally within the chamber 16 of the syringe body 14, thereby expelling the flush solution through the opening 22 in the syringe tip 18, through the needleless connector 26, and into the indwelling IV catheter.

[0034] As shown in FIGS. 1-18, sterilization assemblies 10a-10h include a scrub cap 32 and a sterilization cap .

[0035] The scrub cap 32 includes an open proximal end 36, a closed distal end 38, and a sidewall 40 extending from the open proximal end 36 to the closed distal end 38. The sidewall 40, together with the closed distal end 38, define a chamber 42 sized and shaped to receive the needleless connector 26 of an indwelling IV catheter. The scrub cap 32 may be substantially cylindrical. A scrubber 44 and a sterilant 46 are contained in the chamber 42 of the scrub cap 32. The scrubber 44 may be substantially cylindrical and may fill at least a portion of the chamber 42 of the scrub cap 32. The scrubber 44 may be made of a material that can be impregnated with the sterilant 46. The scrubber 44 may be saturated with the sterilant 46 and / or the scrubber 44 may be secured to a proximal portion 48 of the scrub cap 32, and the sterilant 46 may be contained in a distal portion 50 of the scrub cap 32. In some embodiments, the scrubber 44 may be retained in the proximal portion 48 of the scrubbing cap 32 by interaction between a peripheral flange 52 extending radially outward from the scrubber 44 and a ledge 54 extending radially inward from the inner surface 56 of the side wall 40 of the scrubbing cap 32.

[0036] In some embodiments, the outer diameter of the proximal portion 48 of the scrubbing cap 32 may be larger than the outer diameter of the distal portion 50 of the scrubbing cap 32, and / or the inner diameter of the proximal portion 48 of the scrubbing cap 32 may be larger than the inner diameter of the distal portion 50 of the scrubbing cap 32. The scrubber 44 may be substantially contained within the proximal portion 48 of the scrubbing cap 32.

[0037] In some embodiments, the scrubber 44 may have at least one slit and / or at least one recess 58 at the proximal end 60 of the scrubber 44. The slit and / or recess 58 may be adapted to receive the needleless connector 26 of an indwelling IV catheter when the needleless connector 26 is inserted into the scrubbing cap 32. For example, the proximal end 60 of the scrubber 44 may have a grid-like slit 58, a slice-like slit 58 in the scrubber 44, or a concave blind hole adapted to receive the needleless connector 26. The slit and / or recess 58 may extend partially through the scrubber 44 in the longitudinal direction of the scrubber 44 from the proximal end 60 of the scrubber 44, or may extend completely through the scrubber 44 in the longitudinal direction of the scrubber 44 from the proximal end 60 of the scrubber 44 to the distal end 62 of the scrubber 44. After insertion of the needleless connector 26 into the scrubber 44, the needleless connector 26 may be sterilized by longitudinally reciprocating (up and down) the connector 26 relative to the scrubber 44 and / or by rotating the connector 26 relative to the scrubber 44. If the scrubber 44 is secured to the proximal portion 48 of the scrubbing cap 32 and the sterilant 46 is contained in the distal portion 50 of the scrubbing cap 32, the needleless connector 26 may be longitudinally reciprocated relative to the scrubber 44 to alternately immerse the needleless connector 26 in the sterilant 46 and scrub it with the scrubber 44.

[0038] Sterilant 46 may be any suitable sterilizing liquid capable of killing bacteria, fungi, viruses, and other infectious agents. For example, sterilant 46 may be isopropyl alcohol (IPA), an appropriate ratio of chlorhexidine gluconate in IPA, or other sterilants suitable for effective microbial kill in medical applications.

[0039] The open proximal end 36 of the scrub cap 32 is sealed by a removable cover 64. The removable cover 64 may be a film adhered to the open proximal end 36 of the scrub cap 32. The removable cover 64 may include a pull tab 66 extending outward from a seal 68 of the removable cover 64. During use, a medical professional can grasp the pull tab 66 to remove the removable cover 64 from the scrub cap 32. In some embodiments, a peripheral flange 70 may extend radially outward from the open proximal end 36 of the scrub cap 32, and the removable cover 64 may be adhered to the peripheral flange 70. In some embodiments, a support 72 connected to the distal surface of the peripheral flange and extending radially outward from the outer surface of the sidewall 40 of the scrub cap 32 may be provided around the periphery of the peripheral flange 70 to support and strengthen the peripheral flange 70.

[0040] In some embodiments, protrusions 96 may extend radially outward from the outer surface of sidewall 40 of scrub cap 32 to assist the user in gripping scrub cap 32 during removal of removable cover 64 and scrubbing needleless connector 26.

[0041] The sterilization cap 34 includes an open proximal end 74, a closed distal end 76, and a sidewall 78 extending from the open proximal end 74 to the closed distal end 76. The sidewall 78, together with the closed distal end 76, define a chamber 80 sized and shaped to receive the needleless connector 26 of an indwelling IV catheter. The sterilization cap 34 may be substantially cylindrical or may taper proximally such that the outer diameter of the sidewall 78 of the sterilization cap 34 at the open proximal end 74 of the sterilization cap 34 is greater than the outer diameter of the sterilization cap 34 at the closed distal end 76 of the sterilization cap 34. A compressible sponge 82 saturated with sterilant 46 is contained in the chamber 80 of the sterilization cap 34. The sponge 82 is substantially cylindrical and may fill at least a portion of the chamber 80 of the sterilization cap 34.

[0042] In some embodiments, the sponge may be a porous sponge, or the sponge may have at least one slit and / or at least one recess adapted to receive the needleless connector 26 of an indwelling IV catheter when the needleless connector 26 is inserted into the sterilization cap 34.

[0043] In some embodiments, the threads 84 may extend radially inward from the inner surface of the sidewall 78 of the sterilization cap 34. After the needleless connector 26 is inserted into the chamber 80 of the sterilization cap 34, the sterilization cap 34 may be rotated relative to the needleless connector 26 to engage the threads 84 of the sterilization cap 34 with threads or tabs 86 on the needleless connector 26, securing the sterilization cap 34 to the needleless connector 26 and forcing the needleless connector 26 into contact with the sterilant-saturated sponge 82 contained in the chamber 80 of the sterilization cap 34.

[0044] The open proximal end 74 of the sterility cap 34 is sealed by a removable cover 88. The removable cover 88 may be a film adhered to the open proximal end 74 of the sterility cap 34. The removable cover 88 may include a pull tab 90 extending outward from a seal 92 of the removable cover 88. During use, a medical professional can grasp the pull tab 90 to remove the removable cover 88 from the sterility cap 34. In some embodiments, a peripheral flange 94 may extend radially outward from the open proximal end 74 of the sterility cap 34, and the removable cover 88 may be adhered to the peripheral flange 94. In some embodiments, a support connected to the distal surface of the peripheral flange 94 and extending radially outward from the outer surface of the side wall 78 of the sterility cap 34 may be provided around the periphery of the peripheral flange 94 to support and strengthen the peripheral flange 94.

[0045] In some embodiments, protrusions 96 may extend radially outward from the outer surface of the side wall 78 of the sterilization cap 34 to assist the user in gripping the sterilization cap 34 during removal of the removable cover 64 and scrubbing the needleless connector 26.

[0046] A tip cap 98 that fits over and encapsulates the syringe tip 18 of the prefilled syringe 12 extends distally from the closed distal end 76 of the sterilization cap 34 or the closed distal end 38 of the scrub cap 32 .

[0047] The tip cap 98 may include a closed proximal end 100, an open distal end 102, and a sidewall 104 extending from the closed proximal end 100 to the open distal end 102. The sidewall 104, together with the closed proximal end 100, defines a cavity 106 sized and shaped to receive and encapsulate the syringe tip 18 of the syringe 12. The sidewall 104 of the tip cap 98 may be provided with external threads 108 adapted to engage with internal threads 110 of the luer lock 24 surrounding the syringe tip 18. Engagement of the syringe 12 and the tip cap 98 encapsulates the syringe tip 18 in the tip cap 98, thereby keeping the syringe tip 18 sterile until use.

[0048] In one embodiment of the sterile assembly 10a (FIGS. 1-4), the tip cap 98 extends from the closed distal end 38 of the scrub cap 32, and the closed distal end 76 of the sterility cap 34 is removably coupled to the removable cover 64 of the scrub cap 32. The closed distal end 76 of the sterility cap 34 may be coupled to the removable cover 64 of the scrub cap 32 using any suitable coupling that allows the sterility cap 34 to be removed from the removable cover 64 of the scrub cap 32 without removing the removable cover 64 of the sterility cap 34. Examples of such couplings include, but are not limited to, adhesives, glues, ultrasonic welded bonds, etc.

[0049] In some embodiments, the open proximal end 36 of the scrub cap 32 may include a retainer 112. The retainer 112 includes a peripheral flange 114 extending radially outward from the open proximal end 36 of the scrub cap 32 and a retaining sidewall 116 extending proximally from the outer periphery of the flange 114. The retaining sidewall 116 may include a recess 118 through which the pull tab 66 of the removable cover 64 of the scrub cap 32 extends. The closed distal end 76 of the sterility cap 34 is received in the retainer 112. The retainer 112 acts to reduce inadvertent removal of the sterility cap 34 from the scrub cap 32 prior to use.

[0050] In another embodiment of a sterilization assembly 10c (FIGS. 6-8), a tip cap 98 extends from the closed distal end 38 of the scrub cap 32, the sterilization cap 34 is attached to the scrub cap 32 via a removable disk 120, and the open proximal end 36 of the scrub cap 32 may include a retaining portion 112. The retaining portion 112 includes a peripheral flange 114 extending radially outward from the open proximal end 36 of the scrub cap 32 and a retaining sidewall 116 extending proximally from the outer periphery of the peripheral flange 114. The retaining sidewall 116 may include a recess 118 through which the pull tab 66 of the removable cover 64 of the scrub cap 32 extends. The closed distal end 76 of the sterilization cap 34 is received in the retaining portion 112. The disk 120 rests on the peripheral flange 114 of the retaining portion 112 and is held in place by a retaining flange 122 extending radially inwardly around at least a portion of the open proximal end 36 of the retaining sidewall 116, such that the disk 120 is in snap-fit ​​engagement with the scrub cap 32;

[0051] A circumferential groove 124 is provided on the exterior surface of the side wall 78 of the sterility cap 34 at the closed distal end 76 of the sterility cap 34. A flexible annular projection 126 extends proximally from the disc 120. The annular projection 126 is received in the circumferential groove 124 in a snap-fit ​​engagement. Although the circumferential groove 124 and the annular projection 126 are shown as continuous, the circumferential groove 124 and / or the annular projection 126 may be segmented.

[0052] When using these embodiments (FIGS. 4 and 8), the sterilization cap 34 and disk 120 (if present) are detached from the scrub cap 32 and set aside. The removable cover 64 is then removed from the scrub cap 32, and the needleless connector 26 of the indwelling IV catheter is inserted into the chamber 42 of the scrub cap 32 and moved longitudinally and / or rotated relative to the scrubber 44 to scrub the needleless connector 26 and wash the needleless connector 26 with the sterilant 46. The scrub cap 32 is then removed from the prefilled syringe 12. The prefilled syringe 12 is connected to the needleless connector 26, and the needleless connector 26 and the indwelling IV catheter are flushed with fluid from the syringe 12. The syringe 12 is then removed from the needleless connector 26. The needleless connector 26 is again inserted into the chamber 42 of the scrubbing cap 32 and moved longitudinally and / or rotated relative to the scrubber 44 to scrub the needleless connector 26 and may be rinsed with the sterilant 46. A medical solution is injected into the indwelling IV catheter or blood is withdrawn through the indwelling IV catheter. The needleless connector 26 is again inserted into the chamber 42 of the scrubbing cap 32 and moved longitudinally and / or rotated relative to the scrubber 44 to scrub the needleless connector 26 and may be rinsed with the sterilant 46. The prefilled syringe 12 or another prefilled syringe is connected to the needleless connector 26 and the needleless connector 26 and the indwelling IV catheter are flushed with fluid from the syringe 12. The needleless connector 26 may again be inserted into the chamber 42 of the scrubbing cap 32 and moved longitudinally and / or rotated relative to the scrubber 44 to scrub the needleless connector 26 and rinse the needleless connector 26 with the sterilant 46. The locking syringe may then be used to lock the indwelling IV catheter. The removable cover 88 is then removed from the sterilization cap 34, and the sterilization cap 34 is attached to the needleless connector 26.

[0053] In another embodiment of sterile assembly 10b (FIG. 5), a tip cap 98 extends from the closed distal end 76 of the sterilization cap 34, and the closed distal end 38 of the scrub cap 32 is removably coupled to the removable cover 88 of the sterilization cap 34. The closed distal end 38 of the scrub cap 32 may be coupled to the removable cover 88 of the sterilization cap 34 using any suitable coupling that allows the scrub cap 32 to be removed from the removable cover 88 of the sterilization cap 34 without removing the removable cover 88 of the scrub cap 32. Examples of such couplings include, but are not limited to, adhesives, glues, and ultrasonic welded bonds.

[0054] In some embodiments, the open proximal end 74 of the sterilization cap 34 may include a retainer 112. The retainer 112 includes a peripheral flange 114 extending radially outward from the open proximal end 74 of the sterilization cap 34 and a retaining sidewall 116 extending distally from the outer periphery of the peripheral flange 114. The retaining sidewall 116 may include a recess 118 through which the pull tab 90 of the removable cover 88 of the sterilization cap 34 extends. The closed distal end 38 of the scrub cap 32 is received in the retainer 112. The retainer 112 acts to reduce inadvertent removal of the scrub cap 32 from the sterilization cap 34 prior to use.

[0055] Alternatively ( FIG. 9 , sterilization assembly 10d), the scrub cap 32 may be attached to the sterilization cap 34 via a removable disk 120, and the open proximal end 74 of the sterilization cap 34 may include a retaining portion 112. The retaining portion 112 includes a peripheral flange 114 extending radially outward from the open proximal end 74 of the sterilization cap 34 and a retaining sidewall 116 extending distally from the outer periphery of the peripheral flange 114. The retaining sidewall 116 may include a recess 118 through which the pull tab 90 of the removable cover 88 of the sterilization cap 34 extends. The closed distal end 38 of the scrub cap 32 is received in the retaining portion 112. The disk 120 rests on the peripheral flange 114 of the retaining portion 112 and is held in place by a retaining flange 122 that extends radially inward around at least a portion of the proximal end of the retaining side wall 116, so that the disk 120 is in snap-fit ​​engagement with the sterilization cap 34.

[0056] When using these embodiments, the scrub cap 32 and disk 120 (if present) are separated from the sterilization cap 34. The removable cover 64 is then removed from the scrub cap 32, and the needleless connector 26 of the indwelling IV catheter is inserted into the chamber 42 of the scrub cap 32 and moved longitudinally and / or rotated relative to the scrubber 44 to scrub the needleless connector 26 and wash the needleless connector 26 with the sterilant 46. The sterilization cap 34 is then separated from the prefilled syringe 12 and set aside. The prefilled syringe 12 is connected to the needleless connector 26, and the needleless connector 26 and the indwelling IV catheter are flushed with fluid from the syringe 12. The syringe 12 is removed from the needleless connector 26. The needleless connector 26 is again inserted into the chamber 42 of the scrubbing cap 32 and moved longitudinally and / or rotated relative to the scrubber 44 to scrub the needleless connector 26 and may be rinsed with the sterilant 46. A medical solution is injected into the indwelling IV catheter or blood is withdrawn through the indwelling IV catheter. The needleless connector 26 is again inserted into the chamber 42 of the scrubbing cap 32 and moved longitudinally and / or rotated relative to the scrubber 44 to scrub the needleless connector 26 and may be rinsed with the sterilant 46. The prefilled syringe 12 or another prefilled syringe is connected to the needleless connector 26 and the needleless connector 26 and the indwelling IV catheter are flushed with fluid from the syringe 12. The needleless connector 26 may again be inserted into the chamber 42 of the scrubbing cap 32 and moved longitudinally and / or rotated relative to the scrubber 44 to scrub the needleless connector 26 and rinse the needleless connector 26 with the sterilant 46. The removable cover 88 is then removed from the sterilization cap 34, and the sterilization cap 34 is attached to the needleless connector 26.

[0057] In another embodiment (FIGS. 10-18), the scrub cap 32 and the sterilization cap 34 are connected to each other and to the prefilled syringe 12 by a housing 128. The housing 128 includes an open proximal end 130, a closed distal end 132, and a sidewall 134 extending from the open proximal end 130 to the closed distal end 132. The sidewall 134, together with the closed distal end 132, define a cavity 136 sized and shaped to receive at least a portion of the sterilization cap 34 and the scrub cap 32.

[0058] A tip cap 98 adapted to connect to and encapsulate the syringe tip 18 of the prefilled syringe 12 extends distally from the closed distal end 132 of the housing 128 .

[0059] In one embodiment, a tip cap 98 for connecting to and encapsulating the syringe tip 18 extends distally from the closed distal end 132 of the housing 128. The tip cap 98 may include a closed proximal end 100, an open distal end 102, and a sidewall 104 extending from the closed proximal end 100 to the open distal end 102. The sidewall 104, together with the closed proximal end 100, defines a cavity 106 sized and shaped to receive and encapsulate the syringe tip 18 of the syringe 12. The sidewall 104 of the tip cap 98 may be provided with external threads 108 adapted to engage with the internal threads 110 of the luer lock 24 surrounding the syringe tip 12. Engagement of the tip cap 98 with the syringe 12 encapsulates the syringe tip 18 within the tip cap 98, thereby keeping the syringe tip 18 sterile until use.

[0060] The housing 128 may include a body portion 138 and a retaining portion 140. The inner diameter of the retaining portion 140 may be larger than the inner diameter of the body portion 138, which forms a peripheral flange 142 that extends radially inward into the cavity 136 of the housing 128. The outer diameter of the retaining portion 140 of the housing 128 may also be larger than the outer diameter of the body portion 138 of the housing 128. The sidewall 134 of the housing 128 may include a recess 144 through which the pull tab 90 of the removable cover 88 of the sterilization cap 34 extends. The recess 144 may be provided in the retaining portion 140 of the housing 128.

[0061] In a first embodiment of a sterilization assembly 10e (FIGS. 10-13) having a housing 128, a sterilization cap 34 is placed within a cavity 136 of the housing 128 such that the closed distal end 76 of the sterilization cap 34 rests on the closed distal end 132 of the housing 128. A flexible annular projection 146 extends radially inward from the inner surface of the side wall 134 of the housing 128 at the retaining portion 140 of the housing 128. The annular projection 146 is proximal to the open proximal end 74 of the sterilization cap 34. A circumferential groove 148 is provided on the outer surface of the side wall 40 of the scrub cap 32. Although the circumferential groove 148 is shown as continuous and the annular projection 146 is shown as segmented, the circumferential groove 148 and / or the annular projection 146 may be segmented or continuous. The closed distal end 38 of the scrub cap 32 is received within the cavity 136 of the housing 128, with the annular projection 146 of the housing 128 removably received in a peripheral groove 148 of the scrub cap 32 by a snap-fit ​​engagement. The closed distal end 38 of the scrub cap 32 is adjacent the open proximal end 74 of the sterility cap 34, and the open proximal end 36 of the scrub cap 32 extends proximally from the housing 128.

[0062] Alternatively, the annular projection 146 may be provided on the exterior surface of the side wall 40 of the scrubbing cap 32 and the peripheral groove 144 may be provided on the interior surface of the side wall 134 of the housing 128 at the retaining portion 140 of the housing 128 .

[0063] In a second embodiment of a sterile assembly 10g (FIGS. 15-17) having a housing 128, a sterile cap 34 is placed within the cavity 136 of the housing 128 such that the closed distal end 74 of the sterile cap 34 rests on the closed distal end 132 of the housing 128. Threads 150 are provided on the inner surface of the side wall 134 of the retaining portion 140 of the housing 128. A peripheral connecting flange 152 extends proximally from the outer surface of the side wall 40 of the scrub cap 32. The outer surface of the connecting flange 152 is provided with threads 154. The threads 150 on the inner surface of the retaining portion 140 of the housing 128 engage with the threads 154 on the outer surface of the connecting flange 152 of the scrub cap 32 to attach the scrub cap 32 to the housing 128. The longitudinal height of the connecting flange 152, including the threads 154, may be substantially equal to the longitudinal height of the retaining portion 140 of the housing 128. The closed distal end 38 of the scrub cap 32 is received within the cavity 136 of the housing 128 with the threads 150 on the inner surface of the retaining portion 140 of the housing 128 engaging the threads 154 on the outer surface of the connecting flange 152 of the scrub cap 32, the closed distal end 38 of the scrub cap 32 adjacent the open proximal end 74 of the sterility cap 34, and the open proximal end 36 of the scrub cap 32 extending proximally from the housing 128.

[0064] In using these embodiments (FIGS. 13 and 17), the scrub cap 32 is disconnected from the housing 128. The removable cover 64 is then removed from the scrub cap 32, and the needleless connector 26 is inserted into the chamber 42 of the scrub cap 32 and moved longitudinally and / or rotated relative to the scrubber 44 to scrub the needleless connector 26 and rinse the needleless connector 26 with the sterilant 46. The housing 128 is then disconnected from the prefilled syringe 12. The prefilled syringe 12 is connected to the needleless connector 26, and the needleless connector 26 and indwelling IV catheter are flushed with fluid from the syringe 12. The syringe 12 is removed from the needleless connector 26. The needleless connector 26 is again inserted into the chamber 42 of the scrub cap 32 and moved longitudinally and / or rotated relative to the scrubber 44 to scrub the needleless connector 26 and rinse the needleless connector 26 with the sterilant 46. A medical solution is injected into the indwelling IV catheter, or blood is withdrawn through the indwelling IV catheter. The needleless connector 26 is again inserted into the chamber 42 of the scrub cap 32 and moved longitudinally and / or rotated relative to the scrubber 44 to scrub the needleless connector 26 and optionally rinse with a sterilant 46. The prefilled syringe 12 or another prefilled syringe is connected to the needleless connector 26, and the needleless connector 26 and the indwelling IV catheter are flushed with fluid from the syringe 12. The needleless connector 26 is again inserted into the chamber 42 of the scrub cap 32 and moved longitudinally and / or rotated relative to the scrubber 44 to scrub the needleless connector 26 and optionally rinse with a sterilant 46. The locking syringe may then be used to lock the indwelling IV catheter. The sterile cap 34 is removed from the housing 128 , the removable cover 88 is removed from the sterile cap 34 , and the sterile cap 34 is attached to the needleless connector 26 .

[0065] In a third embodiment of a sterilization assembly 10f (FIG. 14) having a housing 128, the scrub cap 32 is placed within the cavity 136 of the housing 128, with the closed distal end 38 of the scrub cap 32 resting on the closed distal end 132 of the housing 128. A flexible annular projection 146 extends radially inward from the inner surface of the side wall 134 of the housing 128 within the retaining portion 140 of the housing 128. The annular projection 146 is proximal to the open proximal end 36 of the scrub cap 32. A circumferential groove 148 is provided on the outer surface of the side wall 78 of the sterilization cap 34. The circumferential groove 148 and / or the annular projection 146 may be segmented or continuous. The closed distal end 76 of the sterilization cap 34 is received in the cavity 136 of the housing 128 with the annular projection 146 of the housing 128 removably received in the peripheral groove 148 of the sterilization cap 34 by snap-fit ​​engagement, the closed distal end 76 of the sterilization cap 34 adjacent the open proximal end 36 of the scrub cap 32, and the open proximal end 74 of the sterilization cap 34 extending proximally from the housing 128.

[0066] Alternatively, an annular projection 146 may be provided on the exterior surface of the side wall 40 of the sterilization cap 34 and a peripheral groove 148 may be provided on the interior surface of the side wall 134 of the housing 128 within the retaining portion 140 of the housing 128 .

[0067] In a fourth embodiment of a sterile assembly 10h (FIG. 18) having a housing 128, the scrub cap 32 is placed within the cavity 136 of the housing 128, with the closed distal end 38 of the scrub cap 32 resting on the closed distal end 132 of the housing 128. Threads 150 are provided on the inner surface of the side wall 132 of the retaining portion 140 of the housing 128. A peripheral connecting flange 152 extends proximally from the outer surface of the side wall 78 of the sterilization cap 34. Threads 154 are provided on the outer surface of the peripheral connecting flange 152. The threads 150 on the inner surface of the retaining portion 140 of the housing 128 engage with the threads 154 on the outer surface of the peripheral connecting flange 152 of the sterilization cap 34 to attach the sterilization cap 34 to the housing 128. The longitudinal height of the peripheral connecting flange 152, including the threads 154, may be substantially equal to the longitudinal height of the retaining portion 140 of the housing 128. The closed distal end 76 of the sterilization cap 34 is received within the cavity 136 of the housing 128 with the threads 150 on the inner surface of the retaining portion 140 of the housing 128 engaging the threads 154 on the outer surface of the connecting flange 152 of the sterilization cap 34, the closed distal end 74 of the sterilization cap 34 adjacent to the open proximal end 36 of the scrub cap 32, and the open proximal end 76 of the sterilization cap 34 extending proximally from the housing 128.

[0068] In using these embodiments, the sterilization cap 34 is disconnected from the housing 128 and set aside. The removable cover 64 is then removed from the scrub cap 34, and the needleless connector 26 is inserted into the chamber 42 of the scrub cap 32 and moved longitudinally and / or rotated relative to the scrubber 44 to scrub the needleless connector 26 and rinse the needleless connector 26 with the sterilant 46. The housing 128 is then disconnected from the prefilled syringe 12. The prefilled syringe 12 is connected to the needleless connector 26, and the needleless connector 26 and indwelling IV catheter are flushed with fluid from the syringe 12. The syringe 12 is removed from the needleless connector 26. The needleless connector 26 is again inserted into the chamber 42 of the scrub cap 32 and moved longitudinally and / or rotated relative to the scrubber 44 to scrub the needleless connector 26 and rinse the needleless connector 26 with the sterilant 46. A medical solution is injected into the indwelling IV catheter, or blood is withdrawn through the indwelling IV catheter. The needleless connector 26 is again inserted into the chamber 42 of the scrub cap 32 and moved longitudinally and / or rotated relative to the scrubber 44 to scrub the needleless connector 26 and optionally rinse with a sterilant 46. The prefilled syringe 12 or another prefilled syringe is connected to the needleless connector 26, and the needleless connector 26 and the indwelling IV catheter are flushed with fluid from the syringe 12. The needleless connector 26 is again inserted into the chamber 42 of the scrub cap 32 and moved longitudinally and / or rotated relative to the scrubber 44 to scrub the needleless connector 26 and optionally rinse with a sterilant 46. The locking syringe may then be used to lock the indwelling IV catheter. The sterile cap 34 is removed from the housing 128 , the removable cover 88 is removed from the sterile cap 34 , and the sterile cap 34 is attached to the needleless connector 26 .

[0069] The use of caps to maintain passive sterilization and a physical barrier on needleless connectors of indwelling IV catheters is recommended in guidelines, including the INS 2021 Standards of Practice for Infusion Therapy. Because caps are a relatively new concept in vascular care, they are still being adopted by clinical facilities and are often overlooked by healthcare professionals. Incorporating sterile and scrub caps into prefilled flushing syringes allows for easy access to the sterile cap during flushing of the indwelling IV catheter and after infusion of medications or withdrawal of fluids through the needleless connector and indwelling IV catheter.

[0070] When combined with a standard prefilled flushing syringe, the sterile assembly of the present invention provides all the components necessary for proper cleaning and sterilization of needleless connectors and indwelling IV catheters in a single device. The sterile assembly of the present invention can be directly implemented into existing prefilled syringes, such as BD PosiFlush™ syringes. No modifications to existing prefilled syringes are necessary because the sterile assembly of the present invention can be threaded directly onto the syringe tip and luer lock of the prefilled flushing syringe, replacing the tip cover.

[0071] While specific embodiments of the present invention have been described above for purposes of illustration, it will be apparent to those skilled in the art that many changes in detail of the present invention may be made without departing from the invention.

Claims

1. 1. A sterile assembly for a prefilled flushing syringe, comprising: a scrub cap; and a sterile cap removably connected to the scrub cap, The scrub cap is an open proximal end, a closed distal end, and a sidewall extending from the open proximal end of the scrubbing cap to the closed distal end of the scrubbing cap; a chamber defined by the sidewall of the scrub cap together with the closed distal end of the scrub cap, the chamber being sized and shaped to receive a needleless connector of an intravenous (IV) catheter; a scrubber and a sterilant contained within a chamber of the scrubbing cap; Including, Sterile caps are an open proximal end, a closed distal end, and a sidewall extending from the open proximal end of the sterile cap to the closed distal end of the sterile cap; a chamber defined by the sidewall of the sterile cap together with the closed distal end of the sterile cap, the chamber being sized and shaped to receive the needleless connector of the IV catheter; a compressible sponge and sterilant contained in a chamber of the sterilization cap; Contains A sterile assembly comprising:

2. 10. The sterilization assembly of claim 1, wherein the scrubber fills at least a portion of the chamber of the scrubbing cap.

3. 10. The sterilization assembly of claim 1, wherein the scrubber is saturated with sterilant and / or the scrubber is secured to a proximal portion of the chamber of the scrubbing cap and the sterilant is contained in a distal portion of the chamber of the scrubbing cap.

4. 4. The sterilization assembly of claim 3, wherein the scrubber is retained proximal to the scrubbing cap by interaction between a peripheral flange extending radially outward from the scrubber and a ledge extending radially inward from the inner surface of the side wall of the scrubbing cap.

5. 10. The sterile assembly of claim 1, wherein an outer diameter of the proximal portion of the scrubbing cap is greater than an outer diameter of the distal portion of the scrubbing cap and / or an inner diameter of the proximal portion of the scrubbing cap is greater than an inner diameter of the distal portion of the scrubbing cap.

6. 6. The sterilization assembly of claim 5, wherein the scrubber is substantially contained within the proximal portion of the scrubbing cap.

7. 2. The sterile assembly of claim 1, wherein the scrubber has at least one slit and / or at least one recess at a proximal end of the scrubber, the at least one slit and / or the at least one recess adapted to receive a needleless connector of an IV catheter when the needleless connector is inserted into the scrubbing cap.

8. 10. The sterile assembly of claim 1, wherein the open proximal end of the scrubbing cap is sealed by a removable cover.

9. 9. The sterile assembly of claim 8, wherein the removable cover is a film adhered to the open proximal end of the scrubbing cap.

10. 9. The sterile assembly of claim 8, wherein the removable cover includes a pull tab extending outwardly from the seal of the removable cover.

11. 9. The sterile assembly of claim 8, wherein a peripheral flange extends radially outward from the open proximal end of the scrubbing cap, and the removable cover is adhered to the peripheral flange.

12. 10. The sterilization assembly of claim 1, wherein the compressible sponge fills at least a portion of the cavity of the sterilization cap.

13. 2. The sterile assembly of claim 1, wherein the inner surface of the side wall of the sterile cap is threaded.

14. 10. The sterile assembly of claim 1, wherein the open proximal end of the sterile cap is sealed by a removable cover.

15. 15. The sterile assembly of claim 14, wherein the removable cover is a film adhered to the open proximal end of the sterile cap.

16. 15. The sterile assembly of claim 14, wherein the removable cover includes a pull tab extending outwardly from the seal of the removable cover.

17. 15. The sterile assembly of claim 14, wherein a peripheral flange extends radially outward from the open proximal end of the sterile cap, and the removable cover is adhered to the peripheral flange.

18. 10. The sterile assembly of claim 1, wherein protrusions extend radially outward from the outer surface of the scrub cap to assist a user in gripping the scrub cap during removal of the removable cover and scrubbing the needleless connector, and / or protrusions extend radially outward from the outer surface of the side wall of the sterility cap to assist a user in gripping the sterility cap during removal of the removable cover and placement of the sterility cap on the needleless connector.

19. 10. The sterile assembly of claim 1, further comprising a tip cap extending distally from the closed distal end of one of the sterilization cap and the scrub cap and adapted to connect to and encapsulate the syringe tip of a prefilled flushing syringe.

20. 20. The sterile assembly of claim 19, wherein the tip cap includes a closed proximal end, an open distal end, and a sidewall extending from the closed proximal end to the open distal end, the sidewall of the tip cap together with the closed proximal end of the tip cap defining a cavity sized and shaped to receive and encapsulate the syringe tip of the flushing syringe.

21. 21. The sterile assembly of claim 20, wherein the sidewall of the tip cap includes external threads adapted to engage the internal threads of a luer lock surrounding the syringe tip.

22. 10. The sterilization assembly of claim 1, wherein a closed distal end of one of the sterilization cap and the scrub cap is joined to an open proximal end of the other of the sterilization cap and the scrub cap.

23. 10. The sterilization assembly of claim 1, wherein the open proximal end of one of the sterilization cap and the scrub cap includes a retaining portion, the retaining portion including a peripheral flange extending radially outward from the open proximal end of the one of the sterilization cap and the scrub cap, and a retaining sidewall extending distally from an outer periphery of the peripheral flange.

24. 24. The sterilization assembly of claim 23, wherein the closed distal end of the other of the sterilization cap and the scrub cap is received in the retainer.

25. 10. The sterilization assembly of claim 1, wherein one of the sterilization cap and the scrub cap is attached to the other of the sterilization cap and the scrub cap via a removable disk, and wherein an open proximal end of one of the sterilization cap and the scrub cap has a retaining portion to which the removable disk can be removably attached.

26. 26. The sterile assembly of claim 25, wherein the retainer includes a peripheral flange extending radially outward from the open proximal end of one of the sterilization cap and the scrub cap and a retaining sidewall extending distally from an outer periphery of the peripheral flange, the removable disk resting on the peripheral flange of the retainer and held in place by the retaining flange extending radially inward around at least a portion of the proximal end of the retaining sidewall, and the removable disk is in snap-fit ​​engagement with one of the sterilization cap and the scrub cap.

27. 26. The sterilization assembly of claim 25, wherein the outer surface of the side wall of the other of the sterilization cap and the scrub cap is provided with a peripheral groove at the closed distal end thereof, and a flexible annular projection extends proximally from the removable disc, the annular projection being received in the peripheral groove by snap-fit ​​engagement.

28. 10. The sterilization assembly of claim 1, wherein the scrub cap and the sterilization cap are connected by a housing.

29. 29. The sterile assembly of claim 28, wherein the housing includes an open proximal end, a closed distal end, and a sidewall extending from the open proximal end to the closed distal end, the sidewall of the housing defining a cavity together with the closed distal end of the housing, the cavity being sized and shaped to receive one of the sterilization cap and the scrub cap and at least a portion of the other of the sterilization cap and the scrub cap.

30. 30. The sterile assembly of claim 29, further comprising a tip cap extending distally from the closed distal end of the housing and adapted to connect to and encapsulate the syringe tip of the prefilled flushing syringe.

31. 31. The sterile assembly of claim 30, wherein the tip cap includes a closed proximal end, an open distal end, and a sidewall extending from the closed proximal end to the open distal end, the sidewall of the tip cap defining a cavity together with the closed proximal end of the tip cap, the cavity being sized and shaped to receive and encapsulate the syringe tip of the prefilled flushing syringe.

32. 30. The sterilization assembly of claim 29, wherein the housing includes a body portion and a retainer portion, and wherein one of the sterilization cap and the scrub cap is connected to the retainer portion of the housing.

33. 33. A sterile assembly according to claim 32, characterized in that the inner diameter of the holding portion of the housing is larger than the inner diameter of the main body of the housing and / or the outer diameter of the holding portion of the housing is larger than the outer diameter of the main body of the housing.

34. 30. The sterilization assembly of claim 29, wherein the side wall of the housing includes a recess, and wherein a pull tab on a cover of one of the sterilization cap and scrub cap extends through the recess.

35. 30. The sterile assembly of claim 29, wherein one of the sterilization cap and the scrub cap is disposed within a cavity of a housing, a closed distal end of the one of the sterilization cap and the scrub cap rests on the closed distal end of the housing, a closed distal end of the other of the sterilization cap and the scrub cap is received within the cavity of the housing and is removably connected to the housing, an open proximal end of the one of the sterilization cap and the scrub cap is adjacent the closed distal end of the other of the sterilization cap and the scrub cap, and the open proximal end of the other of the sterilization cap and the scrub cap extends proximally from the housing.

36. 30. The sterilization assembly of claim 29, wherein a flexible annular projection extends radially inward from an inner surface of a side wall of the housing, a peripheral groove is provided on an outer surface of a side wall of one of the sterilization cap and the scrub cap, and the annular projection is removably received in the peripheral groove by a snap-fit ​​engagement to connect one of the sterilization cap and the scrub cap to the housing.

37. 30. The sterilization assembly of claim 29, wherein a peripheral groove is provided on the inner surface of the side wall of the housing, and a flexible annular projection extends radially outward from the outer surface of the side wall of one of the sterilization cap and scrub cap, the annular projection being removably received within the peripheral groove by a snap-fit ​​engagement to connect the one of the sterilization cap and scrub cap to the housing.

38. 30. The sterile assembly of claim 29, wherein threads are provided on the inner surface of the side wall of the housing, and a peripheral connecting flange extends proximally from the outer surface of the side wall of one of the sterilization cap and the scrub cap, the connecting flange being threaded on its outer surface, the threads on the outer surface of the connecting flange engaging the threads on the inner surface of the side wall of the housing to attach one of the sterilization cap and the scrub cap to the housing.

39. a syringe including a chamber having a syringe tip defining a lumen having an opening through which the flush solution can be expelled from the chamber; 20. A sterile assembly according to claim 19. wherein the sterile assembly and the syringe are connected by an engagement portion provided between the tip cap and the syringe tip.

40. a syringe including a chamber having a syringe tip defining a lumen having an opening through which the flush solution can be expelled from the chamber; A sterile assembly according to claim 30; wherein the sterile assembly and the syringe are connected by an engagement portion provided between the tip cap and the syringe tip.

41. 1. A method for sterilizing an indwelling IV catheter, the method comprising: Providing a pre-filled flushing syringe according to claim 39; separating the sterilization cap from the scrub cap; removing the cover of the scrub cap; inserting a needleless connector of an IV catheter into a chamber of the scrub cap; scrubbing the needleless connector by longitudinally moving the needleless connector and / or rotating the needleless connector relative to the scrubber and cleaning the needleless connector with a sterilant; detaching either a sterilization cap or a scrub cap connected to the syringe from the syringe; connecting a syringe to the needleless connector and flushing the needleless connector and catheter with a flushing solution; Disconnecting the syringe from the needleless connector; encapsulating the needleless connector with a sterile cap; A method comprising:

42. 1. A method for sterilizing an indwelling IV catheter, the method comprising: Providing a pre-filled flushing syringe according to claim 40; separating the sterilization cap from the scrub cap; removing the cover of the scrub cap; inserting a needleless connector of an IV catheter into a chamber of the scrub cap; scrubbing the needleless connector by longitudinally moving the needleless connector and / or rotating the needleless connector relative to the scrubber and cleaning the needleless connector with a sterilant; Separating the housing from the syringe; connecting a syringe to the needleless connector and flushing the needleless connector and catheter with a flushing solution; Disconnecting the syringe from the needleless connector; encapsulating the needleless connector with a sterile cap; A method comprising:

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